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LEVITRA Drug Profile

Which patents cover Levitra, and what generic alternatives are available?

Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has fifty-four patent family members in thirty-one countries.

The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.

Summary for LEVITRA

International Patents:	54
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	141
Clinical Trials:	24
Patent Applications:	1,833
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LEVITRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVITRA
DailyMed Link:	LEVITRA at DailyMed

Drug patent expirations by year for LEVITRA

Recent Clinical Trials for LEVITRA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
A2 Healthcare Taiwan Corporation	Phase 1/Phase 2
Tritech Biopharmaceuticals Co., Ltd.	Phase 1/Phase 2
Azienda USL Modena	Phase 2

See all LEVITRA clinical trials

Recent Litigation for LEVITRA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Bayer Pharma AG v. Par Pharmaceutical Inc.	2013-05-14
Bayer Pharma AG v. Watson Laboratories, Inc.	2012-04-25
Bayer Schering Pharma AG v. Teva Pharmaceuticals USA Inc.	2010-07-20

See all LEVITRA litigation

Pharmacology for LEVITRA

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

US Patents and Regulatory Information for LEVITRA

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003		DISCN	Yes	No	See Pricing	See Pricing				See Pricing
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003	AB	RX	Yes	Yes	See Pricing	See Pricing				See Pricing
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-001	Aug 19, 2003	AB	RX	Yes	No	See Pricing	See Pricing	Y			See Pricing
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003	AB	RX	Yes	Yes	See Pricing	See Pricing	Y			See Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for LEVITRA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-001	Aug 19, 2003	See Pricing	See Pricing
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003	See Pricing	See Pricing
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003	See Pricing	See Pricing
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003	See Pricing	See Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Paragraph IV (Patent) Challenges for LEVITRA

Drugname	Dosage	Strength	RLD	Date
➤ Subscribe	Tablets	2.5 mg	➤ Subscribe	See Pricing
➤ Subscribe	Tablets	5 mg ad 10 mg	➤ Subscribe	See Pricing
➤ Subscribe	Tablets	20 mg	➤ Subscribe	See Pricing

International Patents for LEVITRA

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Country	Patent Number	Estimated Expiration
South Korea	101172539	See Pricing
Croatia	P20131002	See Pricing
Germany	10232113	See Pricing
Israel	166162	See Pricing
>Country	>Patent Number	>Estimated Expiration

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